EP2558294A1

EP2558294A1 - Multilayered film, use of a multilayered film and process for producing a multilayered film

Info

Publication number: EP2558294A1
Application number: EP11710181A
Authority: EP
Inventors: Thomas Kreischer; Jörn HÖRMANN; Franz Kugelmann
Original assignee: Fresenius Medical Care Deutschland GmbH
Current assignee: Fresenius Medical Care Deutschland GmbH
Priority date: 2010-04-13
Filing date: 2011-03-22
Publication date: 2013-02-20
Anticipated expiration: 2031-03-22
Also published as: KR101793190B1; EP2558294B1; ES2664197T3; WO2011128185A1; CN102844187A; US20130072895A1; KR20130097066A; US9248625B2; CN102844187B; DE102010014785A1

Abstract

The invention specifies a multilayered film, having one or two outer layers, for medical purposes, the outer layers comprising: a first polyalphaolefin; a first thermoplastic elastomer having a melt viscosity with a melt flow index according to ISO 1133 of 0.001 to 6 g/10 min at 230°C, 2.16 kg; and a second thermoplastic elastomer having a high melt viscosity which cannot be measured according to ISO 1133 and is higher than the melt viscosity of the first thermoplastic elastomer.

Description

Multilayer film, use of a multilayer film and method for producing a multilayer film

The present invention relates to a multilayer film for medical purposes, a use of the multilayer film for the production of bags for receiving blood or

Blood components or medical solutions, a use of multi-layer film in medical pumps and a

Process for producing the multilayer film. Further

The invention relates to the use of the multilayer film for producing a multi-chamber bag for use in hemodialysis or peritoneal dialysis or a hemodialysis or Peritonealdialysevorrichtung, in particular as a container for a dialysis fluid in a hemodialysis or

Peritoneal dialysis device.

Hemodialysis or peritoneal dialysis machines are in

different versions known. The mass transfer in the hemodialysis and other extracorporeal blood treatment therapies ^¬ between the blood and the dialysis fluid takes place in a dialyzer, the first one

Flow path for the blood and a second flow path for the dialysis fluid, both flow paths are usually separated by a semi-permeable membrane. The first flow path is part of an extracorporeal blood circulation with a supply line and a return line for the blood and possibly a blood flow supporting pump. The second flow path is provided with means for supplying and discharging the

Dialysis fluid connected. In addition to the so-called single-path systems, in which the continuously supplied dialysis fluid passes only once the dialyzer and then discarded, so-called batch systems are known. DE 31 15 665 C2 describes such a hemodialysis machine, with a against the

Atmosphere sealed volume rigid container works completely fresher before beginning treatment

Dialysis fluid is filled. During operation, the liquid from the container is pumped through the dialyzer and the spent liquid is returned to the container.

A mixture of fresh and spent

Dialysis fluid is avoided in the known hemodialysis apparatus in that the removal of the dialysis fluid takes place in the upper region of the container, while the

Return in the lower tank area takes place. The

Sublayering of the fresh dialysis fluid with the used dialysis fluid remains through the

Maintaining a vertical temperature gradient in the container from top to bottom stable.

The container is made of glass, which has hygienic and bacteriologically favorable properties compared to other materials because of the non-porous surface. In addition, glass is largely resistant to being considered

Chemicals, easy to clean and physiologically harmless. The handling of such reusable

Glass container proves to be complicated by the required before re-dialysis treatment disinfection of the glass container.

US 4,767,526 also describes a dialysis machine in which the dialysis fluid is provided in a container becomes. To avoid disinfection, it is proposed to line the container with a flexible bag which is discarded after use. As containers for holding medical fluids, flexible plastic bags are known, which are made of two flat

superimposed and at their edges with each other

welded films consist. DE 19825158 C1 also describes a disposable bag for a hemodialysis device or a device for

Peritoneal dialysis, preferably a concentrate for

Production of dialysis fluid has. This bag may consist of a chamber in the course of the

Dialysis process, the spent fluid is layered under the fresh dialysis fluid. Alternatively, the disposable bag may also contain a film containing the

Bag separates into two chambers, wherein in one chamber of the bag, the fresh dialysis fluid is present and in the other chamber during the dialysis process, the spent liquid is passed.

In the case of the above-mentioned containers made of glass, it is unfavorable that rapid reuse can not take place due to the complicated disinfecting step. Disposable bags, which make this disinfection step unnecessary, however, still do not solve the problem that react with a granules presented during the storage of the bag and granules during storage of the bag, including the granules, the various components of the granules with each other, so that a storage stability over a certain period does not exist is. In addition, dialysis fluids made by dissolving a granule containing all the necessary ingredients often have the problem that due to undesirable reaction different ingredients not all the granules in

Solution goes. Furthermore, it is important while filling solvent in the bag with granules to control the pH accordingly, so that unwanted

Precipitates during the dissolution of the granules in the

Liquid can be avoided. If these problems occur, the dialysis fluid is not suitable for the

Hemodialysis or peritoneal dialysis and must be discarded together with bag.

Besides glucose and physiologically essential salts, resp.

If appropriate, dialysis fluids should have a pH in the physiological range (pH between 6.5 and 7.6). Preferably should be considered therapeutically necessary

Buffer component can be used in dialysate bicarbonate. To set this naturally dissolving upon dissolution buffer to a physiological value, a

Acid component needed. As a rule, therefore, at

bicarbonate-containing dialysis solutions initially a

Acid component and a bicarbonate-containing component

submitted. When mixing the aqueous parts of this

The ready-to-use, physiologically buffered dialysis solution is produced as a component. The basic and acidic components must be physiologically compatible when mixed together. As a physiologically essential ion, the solution in addition to sodium and potassium and calcium and

Contain magnesium ions. In batch dialysis, the volume required for a treatment center is determined

Dialysis fluid completely submitted. In other

Method, the dialysate is produced online on the dialysis machine. A dialysis fluid is usually prepared from a single concentrate, which is presented in the case of DE 198 25 158 in a disposable bag. Are such concentrates, the slightly soluble calcium or magnesium salts and as basic buffer component containing a (bi) carbonate salt, stored for a long time, so at least under

humidify conditions the problem that the components react with each other and thus poorly soluble Calciumbzw. Magnesium carbonate can form. Likewise, sparingly soluble calcium or magnesium carbonate precipitates out of a solution whose pH is not set in the ideal range of preferably <pH 8. Therefore, it is unfavorable to present a concentrate together with all the necessary physiologically essential components in a bag, since such systems can not be stored for a long time because of the above-mentioned problems, and since in the dissolution in a liquid in some areas in the solution, a pH of about 8 present, so that it comes to unwanted precipitation.

According to the German patent application with the application number DE 102009058445, whose complete disclosure is hereby by

Reference is therefore made, therefore used for medical purposes multi-chamber bag, which allow a

To dissolve concentrate in / with a liquid or by mixing, by breaking a separator between chambers of the multi-chamber bag and dissolving and / or mixing of the concentrate in or with the liquid. If the multi-chamber bag contains a total of at least two chambers, then these can

Concentrates of the same or different composition are present. By breaking through the separator

between the chambers of the bag, a resulting chamber is created whose volume comprises the sum of the volumes of the chambers of the multi-chamber bag. In this way, different substances and / or liquids from different chambers only come into contact with each other during preparation after breaking through the separating device. As multi-chamber bag is a film bag, which consists of a flexible plastic film. The foil bag is for example made of a single or multi-layered

Formed plastic film, wherein the innermost film layer is a weldable film layer. The separating device between the chambers of the bag is formed for example by welding two opposite in the bag inner layers of film to a tear seam. Accordingly, one understands in this

Connection under a tear seam, e.g. linear

Welding of two opposite inner sides of the bag. For example, the tear seam runs in the bag such that the chambers are separate from each other, i. the interiors of the chambers are not connected.

However, for example, by introducing a liquid, the tear seam is broken, so that the previously separate spaces are in communication.

For example, the tear seams of the bag are so-called

Peel seams. These are for example under heat treatment and joining two opposite foil sections

produced. Peel seams have the advantage that they are generally solvable without film breakage.

The said bags are preferably foil bags.

For example, the bags are made of a film that consists of one piece. In other words, the film delimiting the outer dimension of the bag is one

Piece of film. It is preferably sterile in its interior. The state of the materials and articles achieved by a process whereby the materials and articles are released from living microorganisms is said to be sterile. In practice, however, a complete sterilization does not succeed with 100% certainty. It is therefore under "sterilization" or the term "sterile" one Reduction of the number of microorganisms capable of reproduction by a factor determined according to the field of application. Among other things, it is understood that the residual content of microorganisms capable of reproduction in one unit of the

Sterilization material is at most 1CT ⁶ colony-forming units, ie that in one million treated equal

Units of sterilizing a maximum of a reproductive microorganism may be included. The sterilization can be carried out by physical (thermal, irradiated) or chemical methods.

An example of a suitable bag consists of a single or multi-layered film. The innermost layer of the single or multilayer film is a weldable film layer. A particularly desirable separating device, as mentioned above, a tear seam, which is formed by welding two gegenüberlie ^¬ gender innermost film layers and so forms a peel seam. For example, the separator is formed by having a chamber in the bag containing a feed opening for a liquid. By introducing the

Liquid acts on the wall of the chamber which has a tear or peel seam as defined above.

By this pressure, the tear or peel seam is broken, so that the contents of the chamber passes into another chamber, and all dissolved or dissolved concentrates are mixed from the chambers.

If one of the above-mentioned pouches is used in hemodialysis or peritoneal dialysis, it is the one after the

Breaking through the separating devices resulting chamber, which as a volume substantially the sum of the volumes of

entire chambers, for example, a room for

Storage of fresh dialysis fluid. The bag designed in this way can be used in hemodialysis or peritoneal Dialysis, especially as a container for storing

Dialysis fluid in a hemo- or Peritonealdialyse- device used. Such a bag should be able to hold large volumes of liquids and to be sufficiently elastically extensible. Therefore, a film is needed for the

Production of large-volume, stretchable bag is suitable.

Films, in particular elastic stretchable films, for

Use of pouches in medical technology should meet a number of desirable requirements. Desirable properties of such a film are

For example: a suitability of the film material as

medical film; a high flexibility, so that a bag made therefrom large volume quantities, e.g. can absorb up to about 70 1; a high ductility to one

to be able to produce an expandable bag; an elastic stretching behavior with little tendency for plastic deformation; a plastic deformability to be sufficiently deep drawable for the formation of pockets; a heat sterilizability at eg temperatures of approx. 121 ° C; a mechanical stability; a small blocking tendency, that is, adhesion ^¬ pitch, so that mutually opposite inner sides of a bag does not adhere to one another; and a good one

Welding behavior for the formation of peel and permanent welds. Further, for some applications, it is desirable that the film be free of polyethylene and / or polyethylene copolymers. The use of polyethylene and / or polyethylene copolymer packaging can be problematic in that the formulations required for the regulatory

Authorization processes are necessary, often not disclosed by the manufacturers. These requirements are often mutually exclusive and often counteract, so there is still a need for a film with optimal properties. The object is to provide an improved film, in particular a film suitable for the production

large-volume, stretchable bag is suitable.

In one embodiment, therefore, a multi-layer film for medical use is provided, with one or two

Outer layers, the outer layers containing: a first polyalphaolefin; a first thermoplastic elastomer having a melt viscosity of a melt flow index according to ISO 1133 of 0.001 to 6 g / 10 min at 230 ° C, 2.16 kg; and a second thermoplastic elastomer having a melt viscosity not measurable to ISO 1133 which is higher than that

Melt viscosity of the first thermoplastic elastomer.

Another embodiment relates to a use of

Multilayer film for the production of bags for receiving blood or blood components or medical solutions, the thickness of the further layer of the multilayer film being in a range of 100 to 500 μm. In a further embodiment, the multilayer film is used in medical pumps, the thickness of the further layer of the multilayer film being in a range of 50 to 150 μm. According to one embodiment, use of the

Multilayer film provided for making a

Multi-chamber bag for use in hemodialysis or

Peritoneal dialysis or a hemodialysis or

Peritoneal dialysis apparatus, in particular as a container for a dialysis fluid in a hemodialysis

Peritoneal dialysis device.

In a further embodiment, the method of

Preparation of the multilayer film is provided, wherein the multilayer film is produced by coextrusion.

Other features and advantages will become apparent from the following description of embodiments, the figures and the subclaims.

All features of the embodiments described herein and are not mutually exclusively ^¬ sequent can be combined. Like elements of the embodiments are given the same reference numerals in the following description. Elements of one embodiment may be used in the other embodiments without further mention.

Abbreviations used here of material components and their meanings are: PP polypropylene; PE polyethylene; PP-R

Polypropylene random copolymer; SIS styrene-isoprene-styrene copolymer; SEBS styrene-ethylene-butylene-styrene copolymer; SEBS styrene-ethylene-butylene-styrene copolymer; SEPS styrene-ethylene-propylene-styrene copolymer; SEEPS styrene-ethylene-ethylene-propylene-styrene copolymer; PE copolymer polyethylene copolymer.

The term "multilayer film", hereinafter also referred to as film, in the present invention is a film

understood that consists of two or more layers of different or the same material, which may be adhesively bonded together. It is preferred in the context of the present invention that the multilayer film is composed of 2 to 10 layers, wherein a structure from 3 to 7

Layers more preferred and a structure of 3 to 5 layers is particularly preferred. The multilayer film can be produced according to any process which is known to the person skilled in the art as suitable for the purpose according to the invention, for example in a multilayer coextrusion blown film line, flat film line, multilayer coextrusion line or multilayer finish line.

In one embodiment, a multilayer film is provided for medical use, with one or two

Melt viscosity of the first thermoplastic elastomer. The melt flow index of the first thermoplastic elastomer may be in one of the following ranges: from 0.01 to 5.5; from 0.05 to 6; from 0.08 to 4.8; and from 0.01 to 5. The first polyalphaolefin may be present as a base component or matrix in the outer layer.

In accordance with embodiments, a melt viscosity which can not be measured to a high degree according to ISO 1133 means that the

Melt viscosity is so high that it can no longer or reasonably measured according to ISO 1133. The second thermoplastic elastomer with a melt viscosity which is not measurable according to ISO 1133 is also referred to here as the no-flow component. "No Flow" is a manufacturer's specification In the case of no-flow materials, the manufacturers do not provide values for the melt flow index In the context of embodiments, No Flow is understood to mean a melt flow index that is so low that the method ISO 1133 has no characteristic values for the melt flow index Elastomer having a melt viscosity of a melt flow index according to ISO 1133 of 0.001 to 6 g / 10 min at 230 ° C, 2.16 kg is also referred to herein as flow component in the context of embodiments and examples.

One or more of the above-mentioned requirements for a film for medical purposes are met by embodiments of the invention described herein. Preferably, the multilayer film according to embodiments may be three or more

Layers, preferably three to seven layers.

The outer layer or the two outer layers of the film are selected in embodiments of a material that

Prevents injuries to these layers - for example, by the handling of the film - cause undesirable breaking points, which leads to the tearing of the bag during subsequent filling of the resulting bag and the extreme stretching of the bag. Accordingly, in embodiments, the outer layer (s) of the film, in contrast to one or more additional layers that are protected by and surrounded by the outer layer (s), have a higher resistance to mechanical influences.

Furthermore, according to embodiments, the film does not tend to adhere during storage as a multi-chamber bag and during a possible heat sterilization. The film according to

Embodiments make it possible at the same time, preferably at relatively low temperatures, with a corresponding one

Welding tool to produce peeled seams. Peel seams are characterized by the fact that they are partially welded or glued by heat treatment and film

Contact pressure to be produced. Preferably, therefore, the temperature for forming the peel seams is below the welding temperature for permanent welds. A film according to the invention may be due to the choice of

Materials of the outer layer (s) and other layers also have a high elastic extensibility without large force. However, previously known films usually tended to be heated at a temperature of the usual heat sterilization of 100 to 120 ° C. for 5 to 15 minutes (about 10 minutes) at a pressure between 1.5 and 2.5 bar (about 2 bar) unwanted adhesive bonds without contact pressure of appropriate

Welding tools. With the multilayer film according to

However, embodiments will behave like this

avoided.

The multilayer film according to embodiments also makes possible a compromise of partly technically opposing ones

Zesterilisierbarkeit demands of the hit, the adhesion ^¬ behavior, mechanical robustness, the elastic

Extensibility, the manufacturability of permanent and peelable seams and the good separability of the film after the

Heat treatment. It has surprisingly been found that according to embodiments described here, the compound permanently welded seams are broken only by peeling and not by eg foil breakage or delamination. As a "permanent" is in this context a link ^¬ strength to understand a weld, which withstands the loads, in particular filling pressure, which occur in an open bag of a filling volume of up to 120 1,. Under weld seams are to be understood in this context, their strength through heat treatment

to reach. It also includes such seams that reach their strength only due to mechanisms of blocking (surface adhesive forces, adhesive bonds).

With regard to the elastic extensibility of the film and of the bag made therefrom, the film according to embodiments described herein enables a uniform Elongation by force or filling of the bag takes place. In the case of uneven stretching of the bag, there is the danger that individual areas will be overstretched, whereas other areas will not be stretched or stretched less.

In embodiments, the outer layer or one of the outer layers of the film serves as a layer, which faces the interior of the subsequent bag. Furthermore used in execution ^¬ form the outer layer or the outer layers as

Layer facing the outside of the later bag. The outer layer or layers have, according to embodiments, three polymer components, wherein the three polymer components may comprise one base component and two further components. In other embodiments, the outer layer or layers consist essentially of the three polymer components and optional additives. In one example, the outer layer (s) contain or contain the base component and the two other components. In another example, the outer layer (s) contain or contain as the three polymer components

Matrix polymer for one matrix and two phase polymers. As a base component or matrix polymer, for example, polymers with high excitation or melting temperature range, such as. For example, a polyalphaolefin, preferably a polypropylene homopolymer or a polypropylene copolymer can be used. Of the basic components or matrix polymers mentioned, the polypropylene copolymer is preferred. Particularly preferred is a polypropylene random copolymer. As the other two

Components or phase polymers are suitable according to

Embodiments of thermoplastic elastomers ^¬ Licher melt viscosity difference. For example, includes the outer ^¬ layer according to an embodiment, a first thermoplasti ^¬ ULTRASONIC elastomer having a melt viscosity of a melt flow index according to ISO 1133 ^¬ 0.001 to 6 g / 10 min at 230 ° C, 2.16 kg; and a second thermoplastic elastomer having a non-measurable high melt viscosity according to ISO 1133, which is higher than the melt viscosity of the first thermoplastic

Elastomers. The melt flow index of the first thermoplastic elastomer is preferably in one of the following ranges: from 0.01 to 5.5; from 0.05 to 6; from 0.08 to 4.8; and from 0.01 to 5.

According to embodiments, the outer layer (s) of the multilayer film contain or contain a thermoplastic,

preferably a polyalphaolefin, e.g. Polypropylene, which may also be heterophasic. The thermoplastic may be present in the outer layer (s) of the multilayer film as a base component or matrix. Heterophasic means that

different phases may be present. The composition, a heterogeneity and a heterophasic structure of

Outer layer (s) support individually or in any

Combination a good peelability of the later bag welded together, to be peeled layers.

For example, in a base component or matrix formed from the polyalphaolefin, a phase defined by the first thermoplastic elastomer and the second

thermoplastic elastomer is formed. The outer layer or outer layers are due to the invention

Composition heat-usable. The composition of

Outer layers makes it possible that in the bags formed from the multilayer film according to the invention also dry concentrates in chambers by peelable welds from each other

are separated, can be transported without contact to each other. Only at the start of treatment as part of a medical therapy, the chambers can be peeled from each other by entering liquid and thus form a bulky bag. In embodiments, the content of the first thermoplastic elastomer in the outer layer may be 20 to 50% by weight, preferably 25 to 40% by weight, more preferably 25 to 35% by weight, or 20 to 30% by weight. Further, according to embodiments, the content of the second thermoplastic elastomer in the outer layer may be 2 to 20% by weight, preferably 5 to 15% by weight, more preferably 3 to 15% by weight, or 4 to 10% by weight. The remainder of the material of the outer layer may essentially comprise a thermoplastic in the content of 40 to 70%, preferably a

Alphaolefin polymer or copolymer contain, for example, a PP. Alphaolefin polymers and copolymers include polymers having the following general monomer unit CH ₂ CHR:

where R can be: -H, -methyl, -ethyl, -propyl, -propyl-

Isomeric, butyl and butyl isomers, octyl and octyl isomers, generally aliphatic radicals having from 0 to 20 carbon atoms. Particular preference is given to PP, PE, random copolymers and

Block copolymers of propylene, ethylene, butylene, octene and blends of these polymers with one another, copolymers, and

Block copolymers of these polymers.

Surprisingly, the layer structure of the

Multilayer film according to embodiments, in the / the

Outer layer (s) a polyalphaolefin, e.g. a heterophasic polypropylene random copolymer, and two in the

Melt viscosity and molecular weight different thermoplastic elastomers comprises that the multi-layer film peelable and hit zesterilisierbar, is flexible and has other suitable properties suitable for medical purposes. In particular, the outer layer (s) in the multilayer film according to embodiments influence the stretching behavior, the peeling behavior and the adhesion to other film parts. In particular, the use of the invention in the melt highly viscous second thermoplastic elastomer has a positive effect on the adhesion behavior of the outer layer. Furthermore, the proportion and the selection of the lead in the melt

comparatively low viscosity first thermoplastic elastomer for suitable peelability of welds formed between two outer layers. One

particularly suitable peel behavior can be achieved, for example, by so-called heterophasic polypropylene random copolymer, e.g. Bormed SC 220 CF Borealis or SC 820 CF Borealis, e.g. as a basic component or matrix, can be achieved in the outer layer. The proportions of the melt-viscous second thermoplastic elastomer are not prone to sticking because they are typically high molecular weight. The materials of the multilayer film are also selected in embodiments such that the bag is as transparent and flexible, but in particular biocompatible. Out

Biocompatibility reasons and environmental aspects can be the use of PVC, which always has a certain percentage of

Plasticizers, at least in the outer layer, which forms the inner wall after the production of the bag,

be excluded. For the same reasons, materials such. As adhesion promoters that can diffuse into the bag interior, be excluded. For certain

Applications it is also desirable that the

Multilayer film a gas barrier for oxygen and

Having carbon dioxide and a water vapor barrier, which prevents diffusion of these gases both in and out of the bag.

In embodiments, the first polyalphaolefin is selected from: polypropylene, polypropylene copolymer, polypropylene random copolymer, heterophasic polypropylene random copolymer. Furthermore, in embodiments, the first and / or the second thermoplastic elastomer selected from styrene block copolymers, hydrogenated styrene block copolymers, styrene-butadiene-styrene copolymer, styrene-isoprene-styrene copolymer, styrene-ethylene-butylene-styrene copolymer, styrene-ethylene-propylene copolymer, Styrene-ethylene-propylene-styrene copolymer, styrene-ethylene-ethylene-propylene-styrene copolymer, and styrene-ethylene-butylene copolymer.

According to a preferred embodiment, the first polyalphaolefin comprises a heterophasic polypropylene random

copolymer; and / or the first thermoplastic elastomer comprises a styrene-ethylene-butylene-styrene copolymer; and / or the second thermoplastic elastomer is selected from:

Styrene-ethylene-propylene-styrene copolymer, styrene-ethylene-ethylene-propylene-styrene copolymer.

According to one embodiment, the multilayer film comprises a further layer, the further layer containing a third thermoplastic elastomer having a melt viscosity of a melt flow index according to ISO 1133 of 0.001 to 6 g / 10 min at 230 ° C, 2.16 kg and a second polyalphaolefin. The melt flow index of the third thermoplastic elastomer may be in one of the following ranges: from 0.01 to 5.5; from 0.05 to 6; from 0.08 to 4.8; and from 0.01 to 5. The

Melt flow index of the second polyalphaolefin, e.g. PP, may be 3 to 8 g / 10 min, 230 ° C, 2.16 kg.

For example, the second polyalphaolefin, which may be a polypropylene and which forms the phase of the further layer, has a melt viscosity of 4g / 10min melt flow index according to ISO 1133. It may be preferred in a multi-layer composite of the film according to the invention that all layers have an approximately similar stretching behavior. The use of the film is for bags in which portions of the bag wall by filling by a multiple of the Initial dimensions can be stretched. If the layers stretch differently under stress, delaminations may be observed. The mechanical

Strengths such as tear strength or impact resistance would be reduced. In addition to the requirements regarding the stretching behavior, it may be preferred that the outer layer or outer layers have a low tendency to block (heat and pressure sticking) with simultaneous weldability.

The materials of the further layer according to embodiments, which for example is a middle layer arranged between two of the outer layers described here, allow a particularly desired flexibility of the multilayer film and lead to the property of the further layer that it absorbs a stretching energy largely elastically. For example, the further layer contains 70% by weight of SEBS (styrene-ethylene-butylene-styrene copolymer) and 30% by weight of a random

Polypropylene with a share of 4% by weight of ethylene to a particularly suitable stretching behavior of the multilayer film. An improvement in the dimensional stability of the multilayer film during a Hit zesterilisierung can be effected by the fact that the third thermoplastic elastomer in the melt

is low viscosity.

In embodiments, the content of the third thermoplastic elastomer in the further layer may be 40 to 90% by weight, preferably 50 to 80% by weight, more preferably 55 to 75% by weight, and / or the content of the polyalphaolefin in the other layer may be 10 to 60 % By weight, preferably 25 to 45% by weight.

In a multilayer film according to here described

Embodiments is the third thermoplastic elastomer selected from: styrene block copolymers, hydrogenated

Styrene block copolymers, styrene-isoprene-styrene copolymer, styrene-ethylene-butylene-styrene copolymer, styrene-ethylene-propylene copolymer, styrene-ethylene-propylene-styrene copolymer, and styrene-ethylene-ethylene-propylene-styrene Copolymer. In

Embodiments is the second polyalphaolefin selected from polypropylene, polypropylene copolymer, polypropylene random copolymer which may be heterophasic, and polypropylene homopolymer, and optionally comprises an ethylene comonomer.

For example, it is a block-like structure

Copolymers with styrene blocks and blocks consisting of

Copolymers of propyl, butyl and / or ethyl repeating units. According to a preferred embodiment, the third thermoplastic elastomer comprises a styrene-ethylene-butylene-styrene copolymer, and / or the second polyalphaolefin comprises a polypropylene random copolymer or a polypropylene random copolymer with ethylene as comonomer.

In embodiments described herein, the multilayer film has two outer layers and the further layer is disposed between the two outer layers. Embodiments of the multilayer film include one or two outer layers each having a thickness of about 5 to 20 μm, 7 to 20 μm, 10 to 20 μm, 7 to 18 μm and 7 to 15 μm, the further layer having a thickness of about 50 to 500 pm, preferably 50 to 150 pm, may possess.

In addition, in embodiments described herein, the

Multilayer film in one outer layer or in the two outer layers and / or in the further layer of additives in have a content below 5000 ppm or below 200 ppm.

In one embodiment, the multilayer film in

Lengthwise extrusion of the film has an elongation at break of 300% to 750%, preferably 350% to 700%, more preferably 500% to 700% and most preferably 600% to 700%, and in the transverse direction of the extrusion of the film from 300% to 750 %, preferably 350% to 700%, more preferably 500% to 700% and most preferably 600% to 700%. By elongation at break, also called elongation at break, is meant the percentage

Ratio of the change in length AL (at break) to

Initial length and is a measure of the maximum tensile elongation before the tearing of the film. It expresses the ability of one

Material from to follow changes in shape without cracking. The elongation at break is measured by a tensile test according to DIN EN ISO 527-3, on a sample strip of 15 mm width, a clamping length of 50 mm, a pretensioning force of 0.5 N and a feed rate of 200 mm / min. An ability to change the longitudinal direction of the

Extrusion of the film in the above range causes a pouch made from it while it is containing dialysate

(used or fresh) is filled or emptied, subject to a change in volume without cracking before upper limits. This entails that in the unfilled state, only a small amount of material is required, but nevertheless there is a large volume in the filled state. As a result, a product can be provided that only a small amount

Waste volume brings with it. This is particularly desirable in environmental aspects.

Furthermore, in embodiments, the multilayer film may preferably have a tear strength in the longitudinal direction, too

Tensile strength, from 20 N / mm ² to 50 N / mm ² , preferably 25 N / mm ² to 42 N / mm ² , more preferably 30 to 42 N / mm ² , and more preferably 35 N / mm ² to 42 N / mm ² , and in the transverse direction of

Extrusion of the film from 10 N / mm ² to 40 N / mm ² , preferably 15 N / mm ² to 36 N / mm ² , more preferably 20 to 36 N / mm ² , still

more preferably 25 to 36 N / mm ² , and more preferably 30 N / mm ² to 36 N / mm ² .

By "tear resistance" is meant the tensile stress exerted on an article at the moment of rupture The tensile strength is measured in a tensile test according to DIN

Measured according to EN ISO 527-3, on a sample strip of 15 mm

Width, a clamping length of 50 mm, a preload force of 0.5 N and a feed rate of 200 mm / min.

A tear strength is below a lower limit

unfavorable, since the bag otherwise breaks early by overstretching. Above an upper limit of the tear strength, the bag is very tear-resistant, but not sufficiently stretchable.

In addition, according to embodiments, the multilayer film may be stretched by 100% by force of about 10 N, by 400% by about 20 N, and 600% by about 55 N. The

Extensibility was measured here by means of a tensile test of DIN EN ISO 527-3, on a sample strip with a width of 15 mm, a clamping length of 50 mm, a pretensioning force of 0.5 N and a feed rate of 200 mm / min. A high extensibility of the multilayer film has the advantage that the bag in the unfilled state has a small size and thus is easy to handle. In addition, the material requirement is low due to the strong extensibility of the material. Thus, a simpler production and packaging of the material is made possible.

Examples of embodiments described herein are the following three-layer films classified into film types are. In these examples, one of the two outer layers is referred to as the inner layer, ie, the layer enclosing the interior of the bag to be formed therefrom.

Film type 1: Inner layer: Layer thickness: 10 to 20 μm, 10% by weight

Styrene-ethylene-propylene-styrene copolymer Septon 2005, Kuraray (No Flow), 30% by weight of styrene-ethylene-butylene-styrene copolymer Septon 8004

(Melt viscosity <0.1 g / 10min (230 ° C, 2.16Kg), and 60 wt% Random Polypropylene Bormed SC 820 Borealis

Middle layer: Layer thickness: 80 to 150 μm, 30% by weight of styrene-ethylene-butylene-styrene copolymer

Tuftec 1062 Asahi (melt viscosity of about 4 g / 10 min), 70% by weight random polypropylene PP-R RD808 Borealis

Outer layer: analogous inner layer

Film type 2: inner layer: layer thickness: 10 to 20 μm, styrene

Ethylene-ethylene-propylene-styrene copolymer Septon 4077 Kuraray (No Flow), 30% by weight styrene-ethylene-butylene-styrene copolymer Tuftec 1062 Asahi

(Melt viscosity of about 4 g / 10 min), 60

Wt% Random Polypropylene Bormed SC 820 Borealis

Middle layer: Layer thickness: 80 to 150 μm, 70% by weight of styrene-ethylene-butylene-styrene copolymer

Kraton 1645MO Kraton Polymers (melt viscosity of about 4g / 10min), 30% by weight random polypropylene PP-R RD808 Borealis

Outer layer: analogous inner layer Film type 3: Inner layer: Layer thickness: 10 to 20 μm, 15% by weight of styrene-ethylene-propylene-styrene copolymer Septon 2005 Kuraray (No Flow), 25% by weight of styrene-ethylene-butylene-styrene copolymer Kraton 1645MO Kraton

Polymers, and 60% by weight Random Polypropylene Bormed SC 820 Borealis

Septon 8004 Kuraray, 30% by weight random polypropylene, PP-R RD808 Borealis

Outer layer: analogous inner layer

The multilayer film of any of the ones described herein

Embodiments may be used to make pouches for

Intake of blood or blood components or medical solutions are used, the thickness of the others

Layer of the multilayer film is preferably in a range of 100 to 500 pm. Furthermore, the multilayer film according to one of the embodiments described here can be used for use in medical pumps, wherein the thickness of the further layer of the multilayer film preferably in one

Range of 50 to 150 pm. Another use of

Multilayer film according to embodiments is in the production of a multi-chamber bag for use in hemodialysis or peritoneal dialysis or a hemodialysis or peritoneal dialysis device, in particular as a container for a

Dialysis fluid in a hemodialysis or peritoneal dialysis device ^¬.

According to another embodiment, a method for producing the multilayer film according to any of the here described embodiments, wherein the multi-layer film is produced by coextrusion.

In the following, further examples of embodiments will be described with reference to the figures. The figures show:

1 shows a measurement for blocking a film of a

Example;

2 shows a measurement for blocking a film of a

Example;

3 shows a measurement for blocking a film of a

Example;

4 shows a measurement for blocking a film of a

Example;

5 shows the peel force in N as a function of the elongation in% for a film of an example;

Fig. 6 shows the peel force in N as a function of the elongation in% for a film of an example;

7 shows the peel forces of two films of examples in FIG

Dependence on the temperature in the production of Peelnähten; 8 shows an enlargement of FIG. 7 in the region 114 to 124

° C; and 9 shows the peel forces of two films of examples in FIG

Dependence on the temperature in the production of peeled seams. Examples

For Examples 1 to 3 were by coextrusion

Multilayer films were prepared, while for Examples 4 to 6 comparative films were used. The respective examples have the following layer structure:

Example 1 :

Outer layer: layer thickness: 10 pm

60% by weight random polypropylene Bormed SC 220;

5% by weight of styrene-ethylene-butylene-styrene copolymer

Septon 2005 Kuraray;

35% by weight styrene-ethylene-butylene-styrene copolymer Septon 8004 Kuraray

Middle layer: layer thickness: 100 pm

70% by weight of a mixture of 60% by weight styrene-ethylene-butylene-styrene copolymer Septon 8004 Kuraray, 40% by weight Random Polypropylene with 4% by weight ethylene, PP-R RD 204 Borealis;

30% by weight of styrene-ethylene-butylene-styrene copolymer Tuftec H 1221

Outer layer: layer thickness: 10 pm

60% by weight random polypropylene Bormed SC 220;

5% by weight of styrene-ethylene-butylene-styrene copolymer

Septon 2005 Kuraray;

35% by weight styrene-ethylene-butylene-styrene copolymer Septon 8004 Kuraray Example 2:

Outer layer: layer thickness: 10 pm

60% by weight random polypropylene Bormed SC 220;

5% by weight of styrene-ethylene-butylene-styrene copolymer

Septon 4077 Kuraray;

35% by weight of styrene-ethylene-butylene-styrene copolymer Septon 8004 Kuraray middle layer: layer thickness: 100 μm

30% by weight of styrene-ethylene-butylene-styrene copolymer Tuftec H 1221

Outer layer: layer thickness: 10 pm

60% by weight random polypropylene Bormed SC 220;

5% by weight of styrene-ethylene-butylene-styrene copolymer

Septon 4077 Kuraray;

35% by weight styrene-ethylene-butylene-styrene copolymer Septon 8004 Kuraray Example 3

Outer layer: layer thickness: 10 pm

60% by weight random polypropylene Bormed SC 220;

20% by weight of styrene-ethylene-butylene-styrene copolymer

Septon 8004 Kuraray

Middle layer: layer thickness: 100 pm

70% by weight of a mixture of 60% by weight of styrene-ethylene-butylene-styrene copolymer Septon 8004 Kuraray, 40 wt% random polypropylene with 4 wt% ethylene, PP-R RD 204 Borealis;

30% by weight of styrene-ethylene-butylene-styrene copolymer Tuftec H 1221

Outer layer: layer thickness: 10 pm

60% by weight random polypropylene Bormed SC 220;

20% by weight of styrene-ethylene-butylene-styrene copolymer

Septon 8004 Kuraray

Comparative Example 1

Outer layer PP / SEBS PP 40% RD 204 CF; Fa.

Layered Borealis

8 pm SEBS 50% Septon 8004,

Kuraray

Middle layer PE / SEBS SEBS 25% Tuftec H1062,

Schichtd Fa. Asahi

97 pm PE 40% Engage 8003, Fa.

Dow

SEBS 35% Septon 8004, Fa Kuraray

Outer layer PP / SEBS PP 40% RD 204 CF, Fa.

Layered Borealis

15 pm SEBS 60% Septon 8004,

Kuraray

Comparative Example 2

Outer layer PP 100% polypropylene-ethylene

Layer thickness copolymer 4-8% ethylene

20 pm Middle layer PP / SEBS 60% SEBS / 40% PP

layer thickness

120 pm

Outer layer PP 100% polypropylene

layer thickness

20 pm

Comparative Example 3

Outer layer PP 20% SEBS, 80% polypropylene

Schichtd ethylene copolymer 4%

20 pm ethylene content

Middle layer PP / SEBS 35% SEBS, 65% polypropylene layered ethylene copolymer 4%

160 pm ethylene content

Outer layer PP 100% polypropylene-ethylene

Layer thickness copolymer 4% ethylene

20 pm share

Trial 1

In this experiment, a test was performed to test the

Elongation and adhesion behavior of the films of Example 1 (1 piece), Example 2 (three pieces) and Example 3 (three pieces) compared to the film of Comparative Example 1 (two pieces) to determine, each having a thickness of 120 pm had. The respective multilayer films were sterilized at 124.degree. After sterilization, the adhesive behavior of the multilayer films was tested on a 15 mm wide test strip using a tensile tester in a "T" pocket test analogous to that shown in Figs to 4 shown. The figures show measurements for blocking. Fig. 1 shows tensile tests with the film of

Comparative Example 1 again. FIG. 2 shows a tensile test with the film of Example 1. FIG. 3 shows tensile tests with the film of Example 2, and FIG. 4 shows tensile tests with the film of Example 3.

In the tensile tests, the bonding of stacked multilayer films was measured. In order to be able to make a statement about the adhesive behavior, multilayer films corresponding to the bag construction were superimposed, weighted with a weight of a force of approximately 200 to 400 N / mm ² , repackaged and at 124 ° C and 100% more relative

Humidity sterilized for 10 minutes. Bag construction here means that 2 pieces of the respective multi-layer film were superimposed to circumstances of a

emulate exemplary bag. On the ordinate of Figures 1 to 4, the force from the respective tensile test for a 15 mm wide film test strip the

Bag construction reproduced. On the abscissa of Figures 1 to 4, the feed of the clamping jaws is shown. A high force in N as a function of the feed in% means that the 2 pieces of the respective multilayer film adhere to one another. As shown in FIGS. 1 and 4, high forces were measured for the films of Comparative Example 1 and Example 3. In comparison, for the films of the

Examples 1 and 2 measured low forces and therefore show little adhesion of the respective multilayer film to itself. The films of Examples 1 and 2 therefore have no sticking after storage.

Trials 2 and 3 Peel seams were the same in experiment 2 with the films of example 1 and comparative example 1, respectively

Temperatures were established and the peel forces of the peeled seams were compared. The comparisons were made by measuring the peel forces, i. the forces required to peel welds. Furthermore, in experiment 3, the

Determination of Sealing Temperature Curves, Peel Seams of the Films of Example 1 and Comparative Example 1 and the Films of Comparative Examples 2 and 3 at Different

Temperatures generated and the associated Peelkräfte

compared. Sealing temperature curves are here called the peel forces as a function of the temperature during the production of the peel seams. To create the peel seams, a laboratory hot press Hot Tack (Brugger) was used with upper jaws made of metal and lower jaws made of silicone, which could be adjusted to different temperatures. The welding was carried out for a few seconds each with a pressing pressure of 495 N and a welding pressure of 0.1 to 3 N / mm ² .

Trial 2

The peel seams of the films of Example 1 and the

Comparative Example 1 was prepared from 15 mm wide test strips in the Hot Tack Welding Press with a top jaw temperature of 118 ° C, a bottom jaw temperature of 80 ° C, and a weld time of 3 seconds. Then, the generated peel seams were tested by the T-peel test method. The

Tensile tests were carried out in accordance with DIN EN ISO 527-3. The sample strip was clamped to form a "T" shape through the sample strip and the test was performed under the following conditions:

Feed rate of 200 mm / min Measurement of the maximum force occurring in the peel test Clamping length of the test strips: 50 mm

Set pre-load: 0.5 N

Sample width: 15 mm

Tables 1 and 2 and Figures 5 and 6 show the

Test results of the tests, whereby in each case 8 pieces of the

different slides was tested. The lines in the

Force / Strain diagrams of Figures 5 and 6 indicate the test curves for the individual sheets of Nos. 1 to 8 and 9 to 16, respectively, which were used for the tests. The term

Peelkraft, in the Tables 1 and 2 denoted by tensile strength ^¬ net, corresponds to the force that was measured in each case as the force necessary to solve the peel seams.

Table 1

Peeled Sutures Example 1- (Figure 5):

Welding parameters: above 118 ° C, below 80 ° C, t = 3s

Slide remark Tensile strength

No . N (15 mm)

1 Example 1 0.3

2 0.9

3 0.8

4 0,5

5 0.7

6 1.2

7 0.9

8 0.6

Table 2

Peel-seamed pouch Comparative Example 1 (Figure 6):

Welding parameters: above 118 ° C, below 80 ° C, t = 3s Slide remark Tensile strength

No . N (15 mm)

9 Comparative Example 1 1.2

10 1.2

11 1.3

12 0.8

13 1.2

14 1.2

15 1.5

16 0.8

FIG. 5 and Table 1 show the measurement results for the film of Example 1, while FIG. 6 and Table 2 illustrate the measurement results for the film of Comparative Example 1. These two films have comparable softness and flexibility. The film of Example 1 gives peel forces of about 0.3 to 1.2 N / 15mm, with an average of 0.73 N / 15mm at the maximum and a standard deviation of 0.28. The film of Comparative Example 1 gives peel forces of about 0.8 to 1.5 N / 15mm, with an average of 1.15 N / 15mm at the maximum and a standard deviation of 0.24. Thus, the film of Example 1 has the lower peel forces compared to the film of Comparative Example 1. The peel seams of the film of Example 1 thus show an improved

Peelability or peelability.

Experiment 3 The Hot Tack Laboratory Welding Press was used to produce the peel seams to determine the sealing temperature curves using metal upper jaws and lower silicone jaws. The upper jaw was set at various temperatures in the range of 115 to 133 ° C, while the lower jaw constant for the films of Example 1 and Comparative Example 1 to 80 ° C and for the comparison test with the films of Comparative Examples 2 and 3 133 ° C held has been. The welding was carried out for 5 seconds each with a pressing pressure of 495 N and a welding pressure of 0.1 to 3 N / mm. FIGS. 7 to 9, wherein FIG. 8 shows a

Magnification of Figure 7 in the range of 114 to 124 ° C, clearly show the comparatively lower peel forces in the sealing temperature curve, i. the superior peelability of the film of Example 1 over the films of

Comparative Examples 1 to 3. Experiment 3 further shows that peel force ranges of 0.7 to 1.15 N / 15 mm are feasible only with very soft flexible films. Stiffer films, such as those of Comparative ^Examples 2 and 3, do not allow for a reasonably secure seam since, due to the stiffness of the films, external forces primarily affect the peel seams and therefore they open very easily inadvertently. In contrast, peel seams of the film of Example 1, which exhibits low peel forces, are safe due to their soft character and thus the effect of the force on the seam, which is not immediate to the seam

make and do not tend to open unintentionally.

In addition, the film of Example 1, as shown in Experiment 1, proved to be significantly better in terms of the non-stick effect under the influence of temperature compared to the film of Comparative Example 1.

Claims

claims

1. multilayer film for medical purposes, with a

or two outer layers, the outer layers containing:

a first polyalphaolefin;

a first thermoplastic elastomer having a

Melt viscosity of a melt flow index according to ISO 1133 of 0.001 to 6 g / 10 min at 230 ° C, 2.16 kg; and a second thermoplastic elastomer having a melt viscosity not measurably high according to ISO 1133, which is higher than the melt viscosity of the first

thermoplastic elastomer.

2. multilayer film according to claim 1, wherein

the content of the first thermoplastic elastomer in the outer layer is 20 to 50% by weight, preferably 25 to 35% by weight, and / or

the content of the second thermoplastic elastomer in the outer layer is 2 to 20% by weight, preferably 5 to 15% by weight.

3. multilayer film according to any one of the preceding claims, wherein

the first polyalphaolefin is selected from:

Polypropylene, polypropylene copolymer, polypropylene random copolymer, heterophasic polypropylene random copolymer;

and or

the first and / or the second thermoplastic

Elastomer is selected from: styrene block copolymers, hydrogenated styrene block copolymers, styrene-butadiene-styrene copolymer, styrene-isoprene-styrene Copolymer, styrene-ethylene-butylene-styrene copolymer, styrene-ethylene-propylene copolymer, styrene-ethylene-propylene-styrene copolymer, styrene-ethylene-ethylene-propylene-styrene copolymer, and styrene-ethylene-butylene copolymer.

Multilayer film according to one of the preceding claims, wherein

the first polyalphaolefin is a heterophasic

Polypropylene random copolymer comprises; and or

the first thermoplastic elastomer comprises a styrene-ethylene-butylene-styrene copolymer; and / or the second thermoplastic elastomer is selected from: styrene-ethylene-propylene-styrene copolymer, styrene-ethylene-ethylene-propylene-styrene copolymer.

Multilayer film according to one of the preceding claims, comprising:

another layer, with the further layer

contains:

a third thermoplastic elastomer with a

Melt viscosity of a melt flow index according to ISO 1133 of 0.001 to 6 g / 10 min at 230 ° C, 2.16 kg; and a second polyalphaolefin.

A multilayer film according to claim 5, wherein

the content of the third thermoplastic elastomer in the further layer is 40 to 90% by weight, preferably 55 to 75% by weight;

and or

the content of the polyalphaolefin in the further layer is 10 to 60% by weight, preferably 25 to 45% by weight. A multilayer film according to claim 5 or 6, wherein

the third thermoplastic elastomer is selected from styrene block copolymers, hydrogenated styrene block copolymers, styrene-isoprene-styrene copolymer, styrene-ethylene-butylene-styrene copolymer, styrene-ethylene-propylene copolymer, styrene-ethylene-propylene-styrene Copolymer, and styrene-ethylene-ethylene-propylene styrene copolymer;

and or

the second polyalphaolefin is selected from

Polypropylene, polypropylene copolymer, polypropylene random copolymer, and polypropylene homopolymer,

and / or an ethylene comonomer. 8. Multilayer film according to one of claims 5 to 7,

wherein the third thermoplastic elastomer comprises a styrene-ethylene-butylene-styrene copolymer, and / or the second polyalphaolefin comprises a polypropylene random copolymer or a polypropylene random copolymer having ethylene as comonomer.

9. multilayer film according to one of claims 5 to 8,

wherein the multilayer film comprises two outer layers and the further layer between the two

Outer layers is arranged.

A multilayer film according to any one of the preceding claims, wherein the one or two outer layers have a thickness of 5 to 20 μm; and or

wherein the further layer has a thickness of 50 to 500 pm; and or

wherein the multilayer film has at least one element selected from: an elongation at break in

Longitudinal direction of an extrusion of the multilayer film of 300% to 750%; an elongation at break in the transverse direction of the extrusion of the multilayer film of 300% to 750%; a tensile strength in the longitudinal direction of the extrusion of the multi-layer film from 20 N / mm ² to 50 N / mm ² , and a tear strength in the transverse direction of the extrusion

Multilayer film of 10 N / mm ² to 40 N / mm ² .

11. Multilayer film according to one of the preceding claims, wherein the one or two outer layers and / or the further layer have additives in a content below 5000 ppm or below 200 ppm.

12. Use of the multilayer film according to one of

preceding claims for the preparation of bags for receiving blood or blood components or

medical solutions, wherein the thickness of the further layer of the multilayer film is in a range of 100 to 500 pm. 13. Use of the multilayer film according to one of

Claims 1 to 11 in medical pumps, wherein the thickness of the further layer of the multilayer film is in a range of 50 to 150 pm. 14. Use of the multilayer film according to one of

Claims 1 to 11 for the production of a multi-chamber bag for use in hemodialysis or

Peritoneal dialysis or a hemodialysis or

Peritoneal dialysis device, in particular as a container for a dialysis fluid in a hemodialysis or peritoneal dialysis device.

15. Method for producing the multilayer film according to

one of the preceding claims, wherein the Multilayer film is produced by coextrusion.